GlaucoCetin for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medical food called GlaucoCetin to determine if it can improve vision for people with open-angle glaucoma, a condition where eye pressure can damage the optic nerve. Participants will receive either GlaucoCetin or a placebo (a look-alike with no active ingredients) for six months. The goal is to discover if daily GlaucoCetin intake can help protect and support eyesight. Individuals with open-angle glaucoma who have experienced vision loss in the center or sides of their vision might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance vision care for many.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications and supplements, such as Biotin, Ginkgo Biloba, and Citicoline, at least 3 months before starting. If you are on systemic steroids, immunomodulating agents, or certain blood thinners, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that GlaucoCetin is designed to help and protect nerve cells in the eyes of people with open-angle glaucoma. Although specific safety data from studies on GlaucoCetin is not yet available, this trial primarily aims to assess its effectiveness in improving vision and eye function. The main focus is on efficacy rather than safety.
Treatments reaching this stage have typically demonstrated some level of safety in earlier research, suggesting that serious side effects are not expected. However, researchers will closely monitor participants for any possible reactions. If GlaucoCetin had already received FDA approval for another use, it might indicate reasonable safety, but that information is not available here.
In the trial, participants will be randomly assigned to receive either GlaucoCetin or a placebo (a substance with no active ingredients). This setup helps researchers determine if any effects, including side effects, are truly due to GlaucoCetin.12345Why are researchers excited about this trial?
Researchers are excited about GlaucoCetin for glaucoma because it represents a novel approach to treating this eye condition. Unlike traditional treatments such as eye drops or surgeries that focus on reducing eye pressure, GlaucoCetin is a medical food in capsule form designed to support eye health through nutrition. This treatment is particularly promising because it targets the underlying nutritional needs of the eye, potentially providing a new avenue for managing glaucoma, especially for those with peripheral or central visual field loss. This unique method of using a nutritional approach could offer benefits that current pressure-reducing treatments do not address, making it a hot topic in glaucoma research.
What evidence suggests that GlaucoCetin might be an effective treatment for glaucoma?
This trial will compare GlaucoCetin with a placebo in participants with primary open-angle glaucoma. Research has shown that GlaucoCetin is designed to support and protect optic nerve cells, potentially improving vision for those with glaucoma. Early results suggest that taking GlaucoCetin daily for six months can lead to changes in vision and visual acuity. Although detailed information on its efficacy remains limited, the product aims to address nerve damage and loss associated with glaucoma. By targeting these nerve cells, GlaucoCetin may help preserve vision and slow disease progression. While early signs are promising, further research is needed to fully understand its effectiveness.16789
Who Is on the Research Team?
Natasha N Kolomeyer, MD
Principal Investigator
Wills Eye Hospital
Are You a Good Fit for This Trial?
This trial is for people aged 40-80 with open-angle glaucoma, controlled eye pressure, and good visual acuity. Participants must have specific types of visual field defects but no other significant eye diseases or recent surgeries. They shouldn't be on certain medications like nitroglycerin or anti-seizure drugs, nor should they have uncontrolled blood pressure or diabetes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either GlaucoCetin or placebo for 6 months to evaluate changes in vision and visual function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GlaucoCetin
- Placebo
Trial Overview
The study tests GlaucoCetin, a medical food designed to protect optic nerve cells in glaucoma patients against a placebo over six months. Patients are randomly chosen to receive either the treatment or placebo to see if there's an improvement in vision.
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.
Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.
Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.
Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wills Eye
Lead Sponsor
Guardian Health Sciences, Inc.
Collaborator
Published Research Related to This Trial
Citations
GlaucoCetin for Glaucoma · Info for Participants
In a study involving 3,333 glaucoma patients, 79% reported satisfaction with their topical glaucoma medications, indicating a high level of acceptance among ...
A Systematic Review and Network Meta-analysis - PubMed
Conclusions: All active first-line drugs are effective compared with placebo in reducing IOP at 3 months. Bimatoprost, latanoprost, and travoprost are among the ...
3.
ctv.veeva.com
ctv.veeva.com/study/vision-preservation-and-restoration-following-a-6-month-trial-of-glaucocetinVision Preservation and Restoration Following a 6 Month Trial ...
This study is looking at changes in vision and visual function before and after a six month trial of a daily medical food called GlaucoCetin.
Addressing neurodegeneration in glaucoma: Mechanisms ...
In glaucoma, a Phase I clinical trial in 11 primary open-angle glaucoma (POAG) patients showed no safety concerns after intravitreal injection of NT-501 CNTF ...
Niacinamide and Neuroprotection: The Glaucoma Holy Grail
The primary outcome measure is the change in visual field progression over 2 years. The NR as a Neuroprotective Therapy for Glaucoma Trial is also a ...
Vision Preservation and Restoration Following a 6 Month ...
The primary objective of this study is to evaluate the improvement in vision and visual function during a 6 month trial of GlaucoCetin versus placebo in ...
Primary Open-Angle Glaucoma (POAG)
Over 5 years, several studies have shown the incidence of new onset of glaucomatous damage in previously unaffected patients to be about 2.6-3% ...
Primary Open-Angle Glaucoma
Data from the OHTS and EGPS have shown that the risk of developing POAG in these patients can be reduced by using topical therapy to lower IOP.
Primary Open-Angle Glaucoma Polygenic Risk Score and ...
Data for this report were analyzed from November 2023 to June 2024. Exposure: From 1994-2002, participants were randomized to receive topical ...
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